Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS)

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The primary purpose of this study is to evaluate whether treatment with rivaroxaban and aspirin or rivaroxaban alone is better than aspirin alone in prevention of heart attacks, stroke or cardiovascular death in patients with coronary or peripheral artery disease.

A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).

Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily. (Long-term open-label extension was added to make rivaroxaban 2.5 mg twice daily + aspirin 100 mg once daily available to COMPASS trial subjects until the rivaroxaban treatment is commercially available for this indication or for approximately 3 years from regulatory approval of the long term open label extension in a country, whichever comes first.)

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 2.5 mg twice daily, tablet

Drug: Aspirin

Aspirin 100 mg once daily, tablet

Drug: Pantoprazole

Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo

Experimental: Rivaroxaban [5mg] + Placebo(1)

Rivaroxaban 5 mg twice daily and Aspirin Placebo once daily

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 5.0 mg twice daily, tablet

Drug: Aspirin placebo

Placebo(1), matching Aspirin tablets

Drug: Pantoprazole

Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo

Active Comparator: Aspirin + Placebo(2)

Rivaroxaban Placebo twice daily and Aspirin 100 mg once daily

Drug: Aspirin

Aspirin 100 mg once daily, tablet

Drug: Rivaroxaban placebo

Placebo(2), matching Rivaroxaban tablets

Drug: Pantoprazole

Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

-- Coronary or peripheral artery disease

Patients with coronary artery disease must also meet at least one of the following:

Age ≥65, or

Age <65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors